Do you know what it’s like to sit in a meeting and learn that something you hold close as a fundamental principle is probably not as fundamentally true as you thought?
That’s the way I felt earlier this week while attending a meeting on the quality of pharmaceuticals, sponsored by the Food and Drug Administration and Duke University’s Margolis Center for Health Policy.
The meeting—a recording of which is available online—brought together thought leaders from the FDA, Duke, hospital systems, pharmaceutical companies, patient advocates and others including the American Cancer Society to discuss issues surrounding the quality assurance of the medicines we rely on every day.
Some of the information was unsettling:
- The quality of medicines produced in the United States and Europe ranks high. Not so much for those produced in other parts of the world, including China and India
- One pharma executive made the public statement that he would not take medicines manufactured in India or China—if he was even able to determine the country of manufacture, a determination which itself is problematic
- A hospital system pharmacist recounted their experience with a drug used to fight rejection of organ transplants that apparently stopped working on their patients. On further investigation, they found the drug they were using was defective
- A physician recounted their experience with a patient who had advanced heart failure which was well controlled. Suddenly, their condition deteriorated and they had to be admitted to the hospital. Control of the heart failure was achieved, only to recur when the patient went home. This scenario repeated itself several times, until they discovered that the pharmacy that dispensed the medicine to the patient to use at home had a change in manufacturer. Put back on the original prescription, the patient once again did well.
- Another participant recounted that the problems recently encountered with some antihypertensive drugs that led to massive recalls were due to the fact that the manufacturer decided to use a chemical derived from rocket fuel—yes, rocket fuel—that led to contamination with nitrosamines, which are known carcinogens. And that it took months for the knowledge to work its way through the system and lead to a recall.
For me, this is personal.
During the early part of my training and career as a physician I experienced the arguments for and against the use of generic drugs. As I progressed in my career, I used generic medicines whenever possible in the care of my patients. They were far less expensive, and they worked. Today most of the medicines used in this country are generic. Every day I take generic medicines, and so far so good—except for those recalls mentioned above.
Now I am not so certain based on the comments made at this meeting, especially for drugs manufactured in some foreign countries. It appears that their commitment to quality simply isn’t to the level that most of us expect, and that’s a problem.
A couple of months ago a physician colleague of mine raised the question of drug quality—focusing on generics—and said in his opinion that the country of manufacture should be on the bottle label. Honestly, I didn’t see the need at that time.
Fast forward, and I can say that a considerable amount of the discussion during the meeting was exactly on that topic: how can we tell where the drug was manufactured, since the country of origin may influence quality? And that is complicated by the fact that our medicines may have components made in several countries, brought together in one place where they are combined further complicating their origin and other factors that could be problematic such as temperature during transportation.
Compound that with the fact that it is very difficult for a pharmacist, let alone a doctor or patient, to determine the source of the medicine, who really made all the ingredients, and what manufacture lot it came from. Trying to offer a patient who is stable on chronic medications the same medicine from the same manufacturer refill after refill is out the window if the supplier changes. The pharmacist has no way to control the source of many of the medications they dispense to patients. Usually, it is someone else making the decision on which supplier or manufacturer they will be using for that medicine at any point in time.
And then there is the inevitable question: if we really want better assurance that our pills meet quality standards who is going to pay for it?
It was clear from the discussions that cost is the driving factor for many of the medicines we take. Cost to the insurer, cost to the patient, cost to the health system. However, what’s the cost of bad medicines? Who pays for that? Well, all of us to be honest.
Let’s abandon the thought that we don’t care about quality and won’t pay for it.
Decades ago, auto manufacturers in the United States were forced to improve the quality of the cars they produced because autos from Japan and Germany were notably better. Over time, consumers voted with their feet, and quality was force to improve. And today, as noted in the current issue of Consumer Reports, the costs of cars (and our insurance) is increasing because more systems are built in to increase safety, with the hope over time that those costs will stabilize or go down because of improved systems and fewer accidents and serious injuries. Society made a choice that the investment in quality and safety is worth it, when it comes to automobiles.
There is certainly a lot of complexity to solving this problem. The FDA is committed to fixing it, however resources are limited and the solutions are complicated. Even finding the information to assess pharmaceutical quality can be very difficult. Part of the problem is that we need those resources and commitments to get this fixed. That’s a point that everyone in the room agreed on. How we get there won’t be easy. It’s clear we need to get started somewhere.
What about holding some of the companies who have repeated poor quality reports accountable? Should drug distributors and pharmacy benefit managers—who know about these issues—turn their eyes elsewhere when they know this is a problem? Should insurers accept this as status quo and not figure out how to pay for quality medications even if it costs a bit more (which by the way they theoretically could recover if fewer people had their blood pressure poorly controlled because of ineffective medications)?
So, my colleague was right: there is a problem, and to him I say publicly “mea culpa.” And to you I say this is a problem that demands attention. Right now, it is the stuff of experts in the private and non-profit sectors and government agencies. Maybe its time that we as consumers and health professionals increase our awareness, band together, and demand a solution.